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FDA Draft Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings

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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the <em>Draft Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings. </em></p>

Re: Docket No. FDA-2008-D-0417: Draft Guidance for the Public and FDA Staff on

Convening Advisory Committee Meetings; Availability

Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings.

This draftguidance, as part of FDA’s recently released series of Advisory Committee guidances,helps to establish a reasonable framework for Advisory Committee procedures thatpromotes transparency and high ethical standards, while preserving the Agency’s flexibility to obtain needed expert advice on critical scientific and technical matters.

However, BIO suggests that FDA ensure that this draft guidance not compromise the

Agency’s long-standing approach of convening Advisory Committees based on the need to solicit expert external advice relating to scientific, medical, and public health questions, rather than factors relating to non-scientific public discourse or any type of sensationalism.

BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.

GENERAL COMMENTS:

BIO member companies, which are working on the forefront of science, recognize that it is often of paramount importance for FDA to obtain external expertise. FDA Advisory Committees provide such specialized expertise across a wide array of scientific, medical, and technical disciplines. BIO generally supports the development of transparent factors to help determine when an Advisory Committee should be convened. Such established factors can bring additional predictability to the Advisory Committee process and ensure that the valuable time and resources of Agency staff and external experts are utilized most efficiently.

However, BIO believes that, as currently described in the Draft Guidance, the factors listed in Section III will contribute to an environment where science and medical opinion may become secondary to non-expert interpretations that then may be mis-communicated to the public. For example, the Draft Guidance employs phrases such as "significant public interest" and "so controversial,” which are open to such broad interpretation that the process of determining the need to convene Advisory Committees could become bogged down and the committee meetings could be devoted far less to scientific discussions than is in the interest of efficiency and the public health or that has been the traditional intention of these committees.

We encourage the Agency to modify the factors discussed in Section III, to ensure that

FDA discussions with its Advisory Committees are centered on sound science as it relates to appropriate regulatory decisions. We believe the Guidance should state directly that Advisory Committee expertise will be sought to resolve differing scientific and medical opinions, address regulatory decisions with no previous precedent, or resolve questions that require additional specialized scientific or medical expertise.

Specifically, BIO recommends that FDA consider revising the draft guidance to reflect the following factors when determining whether to convene an advisory committee:

(a) Is the matter at issue open to differing scientific and medical interpretation such that it may be highly beneficial to obtain the advice of an Advisory Committee as part of the Agency's regulatory decision-making process?

(b) Does the matter include issues that have yet to be addressed in any previous Agency regulatory decision or has the state of science changed since a regulatory decision was made, such that the expertise of an Advisory Committee is necessary for the Agency to protect the public health?

(c) Is there a special type of expertise that an Advisory Committee could provide that is needed for the Agency to consider this matter fully?

The biotechnology industry shares FDA’s commitment to ensuring that sound scientific and medical judgment is utilized to make regulatory decisions; we believe that the factors above reflect that ideal.

Additionally, the Federal Register Notice and the Background section of the Draft Guidance (page 3) state that, "An advisory committee meeting also provides a forum for a public hearing on important matters." However, we note that the Federal Advisory Committee Act does not provide for the use of Advisory Committee meetings to obtain general public input on issues. The federal government should solicit general public information by holding public hearings under 21 CFR Part 15, rather than through the advisory committee process.

CONCLUSION:

BIO appreciates this opportunity to comment on Draft Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings. We would be pleased to providefurther input or clarification of our comments, as needed.